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114 device results listed.

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IMMUNO-TROL i-Tracker Anti-Risankizumab

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingKitProfessional testingReagent

Manufacturer: BIOSYNEX
Manufacturer SRN: FR-MF-000042615
UDI-DI: 03532672000431
Basic UDI-DI: 353267CTRZ003PCAR8
Reference: CTRZ 003-PC
EMDN: W0102152001
EMDN description: TDM/DRUG CONTROLS
First on market country: France
Authorised representative: -
Last updated: 01.07.2026 12:26

Manufacturer products View details

IMMUNO-TROL i-Tracker Risankizumab

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingKitProfessional testingReagent

Manufacturer: BIOSYNEX
Manufacturer SRN: FR-MF-000042615
UDI-DI: 03532672000424
Basic UDI-DI: 353267CTRZ002PCAQZ
Reference: CTRZ 002-PC
EMDN: W0102152001
EMDN description: TDM/DRUG CONTROLS
First on market country: France
Authorised representative: -
Last updated: 01.07.2026 12:26

Manufacturer products View details

IMMUNO-TROL i-Tracker Anti-Etanercept

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingKitMicrobial substancesProfessional testingReagent

Manufacturer: BIOSYNEX
Manufacturer SRN: FR-MF-000042615
UDI-DI: 03532672000370
Basic UDI-DI: 353267CTE003PCART
Reference: CTE 003-PC
EMDN: W0102152001
EMDN description: TDM/DRUG CONTROLS
First on market country: France
Authorised representative: -
Last updated: 01.07.2026 12:25

Manufacturer products View details

IMMUNO-TROL i-Tracker Etanercept

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingKitProfessional testingReagent

Manufacturer: BIOSYNEX
Manufacturer SRN: FR-MF-000042615
UDI-DI: 03532672000363
Basic UDI-DI: 353267CTE002PCARL
Reference: CTE 002-PC
EMDN: W0102152001
EMDN description: TDM/DRUG CONTROLS
First on market country: France
Authorised representative: -
Last updated: 01.07.2026 12:25

Manufacturer products View details

N aTNFa Controls ETA

IVD Class BIVDR 2017/746On the marketHuman tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Products GmbH
Manufacturer SRN: DE-MF-000005039
UDI-DI: 00630414615509
Basic UDI-DI: 0405686902180VE
Reference: 10873744
EMDN: W0102152001
EMDN description: TDM/DRUG CONTROLS
First on market country: -
Authorised representative: -
Last updated: 26.06.2026 22:55

Manufacturer products View details

N aTNFa Controls INF

IVD Class BIVDR 2017/746On the marketHuman tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Products GmbH
Manufacturer SRN: DE-MF-000005039
UDI-DI: 00630414615424
Basic UDI-DI: 0405686902180VE
Reference: 10873742
EMDN: W0102152001
EMDN description: TDM/DRUG CONTROLS
First on market country: -
Authorised representative: -
Last updated: 26.06.2026 22:55

Manufacturer products View details

Whole Blood Therapeutic Drug Monitoring Control

1 mL×2 (2 levels, lyophilized product)

IVD Class BIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: Beijing Diagreat Biotechnologies Co., Ltd.
Manufacturer SRN: CN-MF-000019511
UDI-DI: 06942293591688
Basic UDI-DI: 697518250P1190775
Reference: P11907
EMDN: W0102152001
EMDN description: TDM/DRUG CONTROLS
First on market country: Italy
Authorised representative: Medunion S.L.
Last updated: 26.06.2026 19:31

Manufacturer products Authorised representative products Authorised representative actors View details

Therapeutic Drug Monitoring Control

1 mL×2 (2 levels, lyophilized product)

IVD Class BIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: Beijing Diagreat Biotechnologies Co., Ltd.
Manufacturer SRN: CN-MF-000019511
UDI-DI: 06942293591657
Basic UDI-DI: 697518250P119016R
Reference: P11901
EMDN: W0102152001
EMDN description: TDM/DRUG CONTROLS
First on market country: Italy
Authorised representative: Medunion S.L.
Last updated: 26.06.2026 19:31

Manufacturer products Authorised representative products Authorised representative actors View details

Emit II Plus Specialty Multi Drug Calibrator/Control Level 3

IVD Class BIVDR 2017/746On the marketHuman tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00630414027951
Basic UDI-DI: 0405686901901VR
Reference: 10720814
EMDN: W0102152001
EMDN description: TDM/DRUG CONTROLS
First on market country: -
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 22.06.2026 16:35

Manufacturer products Authorised representative products Authorised representative actors View details

Emit II Plus Specialty Multi Drug Calibrator/Control Level 2

IVD Class BIVDR 2017/746On the marketHuman tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00630414027968
Basic UDI-DI: 0405686901901VR
Reference: 10720813
EMDN: W0102152001
EMDN description: TDM/DRUG CONTROLS
First on market country: -
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 22.06.2026 16:35

Manufacturer products Authorised representative products Authorised representative actors View details

Emit II Plus Oxycodone Negative Control 300

IVD Class BIVDR 2017/746On the marketHuman tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00630414027982
Basic UDI-DI: 0405686901154V6
Reference: 10720811
EMDN: W0102152001
EMDN description: TDM/DRUG CONTROLS
First on market country: -
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 22.06.2026 16:35

Manufacturer products Authorised representative products Authorised representative actors View details

Emit II Plus Oxycodone Positive Control 100

IVD Class BIVDR 2017/746On the marketHuman tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00630414027999
Basic UDI-DI: 0405686901154V6
Reference: 10720810
EMDN: W0102152001
EMDN description: TDM/DRUG CONTROLS
First on market country: -
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 22.06.2026 16:35

Manufacturer products Authorised representative products Authorised representative actors View details

Emit II Plus Oxycodone Negative Control 100

IVD Class BIVDR 2017/746On the marketHuman tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00630414028002
Basic UDI-DI: 0405686901154V6
Reference: 10720809
EMDN: W0102152001
EMDN description: TDM/DRUG CONTROLS
First on market country: -
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 22.06.2026 16:35

Manufacturer products Authorised representative products Authorised representative actors View details

Emit II Plus Specialty Multi Drug Calibrator/Control Level 1

IVD Class BIVDR 2017/746On the marketHuman tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00630414028026
Basic UDI-DI: 0405686901901VR
Reference: 10720807
EMDN: W0102152001
EMDN description: TDM/DRUG CONTROLS
First on market country: -
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 22.06.2026 16:35

Manufacturer products Authorised representative products Authorised representative actors View details

Mycophenolic Acid Control Level 1

IVD Class CIVDR 2017/746On the marketDirect markingHuman tissuesKitProfessional testingReagent

Manufacturer: More Diagnostics Inc
Manufacturer SRN: US-MF-000019469
UDI-DI: 00856743007079
Basic UDI-DI: 0856743007MDI02406D
Reference: 240-1
EMDN: W0102152001
EMDN description: TDM/DRUG CONTROLS
First on market country: -
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 21.06.2026 23:18

Manufacturer products Authorised representative products Authorised representative actors View details

Mycophenolic Acid Control Level 2

IVD Class CIVDR 2017/746On the marketDirect markingHuman tissuesKitProfessional testingReagent

Manufacturer: More Diagnostics Inc
Manufacturer SRN: US-MF-000019469
UDI-DI: 00856743007086
Basic UDI-DI: 0856743007MDI02406D
Reference: 240-2
EMDN: W0102152001
EMDN description: TDM/DRUG CONTROLS
First on market country: -
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 21.06.2026 23:18

Manufacturer products Authorised representative products Authorised representative actors View details

Mycophenolic Acid Control Level 3

IVD Class CIVDR 2017/746On the marketDirect markingHuman tissuesKitProfessional testingReagent

Manufacturer: More Diagnostics Inc
Manufacturer SRN: US-MF-000019469
UDI-DI: 00856743007093
Basic UDI-DI: 0856743007MDI02406D
Reference: 240-3
EMDN: W0102152001
EMDN description: TDM/DRUG CONTROLS
First on market country: -
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 21.06.2026 23:18

Manufacturer products Authorised representative products Authorised representative actors View details

Mycophenolic Acid Control Level 4

IVD Class CIVDR 2017/746On the marketDirect markingHuman tissuesKitProfessional testingReagent

Manufacturer: More Diagnostics Inc
Manufacturer SRN: US-MF-000019469
UDI-DI: 00856743007109
Basic UDI-DI: 0856743007MDI02406D
Reference: 240-4
EMDN: W0102152001
EMDN description: TDM/DRUG CONTROLS
First on market country: -
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 21.06.2026 23:18

Manufacturer products Authorised representative products Authorised representative actors View details

CUSTOM LIQUID THERAPEUTIC DRUG CONTROL - LEVEL 2

IVD Class BNot specifiedOn the marketNo EU rep

Manufacturer: Randox Laboratories Limited
Manufacturer SRN: XI-MF-000028410
UDI-DI: 05055273217322
Basic UDI-DI: 50552732BLTDCON177KM
Reference: HD3146
EMDN: W0102152001
EMDN description: TDM/DRUG CONTROLS
First on market country: Northern Ireland
Authorised representative: -
Last updated: 21.06.2026 21:35

Manufacturer products View details

CUSTOM LIQUID THERAPEUTIC DRUG CONTROL - LEVEL 3

IVD Class BNot specifiedOn the marketNo EU rep

Manufacturer: Randox Laboratories Limited
Manufacturer SRN: XI-MF-000028410
UDI-DI: 05055273217339
Basic UDI-DI: 50552732BLTDCON177KM
Reference: HD3147
EMDN: W0102152001
EMDN description: TDM/DRUG CONTROLS
First on market country: Northern Ireland
Authorised representative: -
Last updated: 21.06.2026 21:35

Manufacturer products View details